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Insights: Eli Lilly and Company and Actavis UK Limited being heard at the Supreme Court

In July 2015, we reported on the judgement handed down by the UK Court of Appeal in the long running dispute between Actavis UK Limited and Eli Lilly & Company concerning Eli Lilly’s European patent EP1313508 (“the Patent”) – see here. The Patent contains second medical use claims directed to pemetrexed disodium in combination with vitamin B12 for inhibiting tumour growth. Ely Lilly currently market pemetrexed disodium as a cancer treatment under the brand name Alimta. Actavis has been seeking to clear the way to launch products comprising pemetrexed diacid, dipotassium or ditromethamine.

To recap, the Court of Appeal found that Actavis’ products did not directly infringe the Patent in agreement with the first instance decision. However, overturning the first instance decision, the Court of Appeal held that reconstitution of Actavis’ products in saline solution (for administration to a patient) would generate pemetrexed disodium in situ. As a consequence, this led to a finding that any of the pemetrexed salts proposed by Actavis would constitute a “means relating to an essential element of the invention”, as required by Section 60(2) UKPA, resulting in indirect infringement of Lilly’s claim.

The judgment has been appealed to the Supreme Court and is being heard this week. Both the issue of whether or not Actavis’ products indirectly infringe the Patent as well as the issue of whether or not the Patent is directly infringed (by virtue of equivalence under Article 69 EPC) are to be considered by the Court.

In related proceedings, the High Court has already ruled that one of Actavis’ pemetrexed products does not infringe Lilly’s patent, see Actavis & Ors v Eli Lilly [2016] EWHC 234 (Pat). Following the Court of Appeal’s judgment discussed above, Actavis remitted back to the High Court a new issue as to whether reconstitution or dilution of their pemetrexed products in 5% dextrose solution instead of saline would still infringe. Although Eli Lilly accepted that Actavis’ product would not infringe if diluted with dextrose, the point at issue in the judgment was whether it would be foreseeable that saline would be used by some pharmacists instead of dextrose. The High Court judge found in favour of Actavis; however, this decision may be appealed in due course.

We will, of course, report the outcome once the Supreme Court judgment is handed down. Until then, please do not hesitate to contact your usual Boult Wade Tennant adviser with any questions.

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